American Red Cross Fined $9.6 Million for Unsafe Blood Collection

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The American Red Cross, the largest supplier of donated blood in the U.S., was fined $9.6 million after federal inspectors found hundreds of blood safety violations at 16 of the organization's 36 blood collection centers nationwide.

In a 32-page letter to the Washington-based organization, Food and Drug Administration officials describe an all-encompassing lack of controls to ensure the safety of the nation's blood supply. The violations range from understaffing, inadequate staff training, and delayed logging of donations, to ineffective screening of donors, failure to add new donors with infected blood to the national list of deferred donors, failure to share information on deferred donors between facilities, and failure to quarantine and recall infected blood units.

Other lapses include failing to notify health departments when donated blood was found to have been infected with HIV, Hepatitis C, or the West Nile virus, failing to promptly alert healthcare facilities when expired or infected blood had been distributed, failing to register adverse donor reactions as a result of giving blood, and incorrect labeling of blood products.

In addition, the FDA cited the Red Cross for poor quality assurance, including keeping blood products out of controlled storage for more than 30 minutes, a backlog of approximately 18,000 donor management cases, and insufficient record-keeping. Regulators claim the organization allowed employees with no medical training, certification, or experience to serve as Medical Directors in charge of reviewing donor complications, and permitted staff to "perform tasks they did not understand." In some cases, employees failed to identify permanently deferred donors who previously gave blood under different or hyphenated names, and were later attempting to donate using just one part of the hyphenated last name.

The FDA first reported the problems in a 2010 inspection report following a two-month investigation of Red Cross facilities around the country.

"We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made," the Red Cross said in a statement on its website.

The fine is the second time the FDA has punished the organization for shoddy blood screening in as many years, adding to a total of over $47 million since 2003. Then, a consent decree between the two set penalties for running afoul of U.S. laws and regulations concerning blood and blood products. In 2010, regulators fined the Red Cross $16 million for substandard handling of blood products, including red blood cells, plasma, and platelets, and disregard for manufacturing guidelines.

But the FDA stopped short of saying the violations have endangered consumers' health.

"The safety of the nation's blood supply is the FDA's top priority, and the violations that were noted, while significant, have not compromised the safety of the blood supply," said Mary Malarkey, head of compliance at the agency's Center for Biologics Evaluation and Research (CBER), in a telephone interview. "We are encouraging people to donate blood."

Malarkey said her office is working closely with the Red Cross management team to address the issues. A spokesman for CBER said the problems can be partly attributed to a lack of continuity in the organization's leadership team.

"We share the concerns because these violations have been going on for some time, but I am cautiously optimistic," Malarkey said.

Public Citizen, a consumer advocacy group which has campaigned to curb dangerous practices at the Red Cross since 2000, remains critical of the decision. After learning the FDA discussed the possibility of a fine last fall, the group urged the agency to impose the penalty in a letter earlier this month, calling the delay "unreasonable."

"The fine levied by the FDA against the American Red Cross should have been much larger, given the number and duration of the violations identified during the agency's inspection of the [organization's] blood banking facilities. A larger fine would have sent a clearer and more effective message to the American Red Cross leadership," said Michael Carome, deputy director of Public Citizen's health research group, in response to the announcement.

Public Citizen obtained the 2010 inspection report after submitting a Freedom of Information request to the FDA.

Blood donations at the Red Cross account for more than 40% of blood supplied to 3,000 hospitals and transfusion centers nationwide. While the organization does not pay for donations, it charges healthcare facilities for the costs associated with screening donors, collecting and processing the blood, and storage and distribution of blood components.

According to a recent study by the National Center for Biotechnology Information at the National Institutes of Health, the mean acquisition cost for one unit of red blood cells (equal to about a pint) purchased from a supplier is approximately $210, and the mean charge to the patient approximately $344. The average red blood cell transfusion consists of three units of blood.

In this blog I examine the effects of pharmaceutical marketing, inadequate regulations in healthcare, and poor health literacy on human health. I am a M.S. candidate in health policy at the Harvard School of Public Health with a M.A. in journalism from New York University. ...